Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Listed as NCT00428948, this PHASE3 trial focuses on Polycystic Kidney Disease, Autosomal Dominant and remains completed. Sponsored by Otsuka Pharmaceutical Co., Ltd., it has been updated 8 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Aug 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Feb 2017 — Aug 2017 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jan 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Otsuka Pharmaceutical Co., Ltd.
- Otsuka Pharmaceutical Development & Commercialization, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .